Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients

NCT03783494 | Completed Phase 4

• 1 other identifier: 18-PP-04
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally. In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures

Conditions

Joint Dislocation; Limb Fracture

Keywords

ED; dislocation reduction; emergency department; TCI; Target-controlled infusion; sedation; fracture reduction

Outcome Measures

Primary Outcomes (1)

• Propofol brain concentration

  Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce\_Ramsay5)

  Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)

Secondary Outcomes (2)

• Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)

  the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]

• Propofol brain concentration when the patient spontaneously reopen his eyes (Ce_OuvertureYeux)

  Time after T0 when the patient spontaneously reopen his eyes (up to an anticipated average maximal time of 30 minutes after T0)

Study Arms (1)

Target-controlled infusion (TCI)

EXPERIMENTAL

Target-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes

Drug: Target control infusion with propofol

Interventions

Target control infusion with propofol DRUG

Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures

Target-controlled infusion (TCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 or more
• Affiliated or beneficiary of a French health insurance system
• Indication of procedural sedation, by the emergency department physician in the context of the management of for a patient with an orthopedic lesion requiring a potentially painful emergentcy therapeutic actionprocedure (reduction of a joint dislocation or realignment of a limb displaced fracture)
• For women :
• at childbearing age : effective contraception (oral, intra-uterine device or condoms)
• objective infertility (diagnosis or surgically)

You may not qualify if:

• Patient of more than 18 under legal protection or deprivation of liberty measures
• Ongoing pregnancy or breastfeeding women
• Known hypersensitivity to propofol or one of the excipients, egg, sojasoya or peanuts
• ASA comorbidity score of 4 or more
• Heart, respiratory, renal or hepatic failure
• Epilepsy
• Lipid metabolism disorder
• Mitochondrial disease
• Hemodynamic instability, multiple traumatism
• Elevated intracranial tension
• Drug or alcohol intoxication
• Simultaneous participation to another interventional study

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Emergency Department

Nice, 06000, France

Location

Related Publications (1)

• Lemoel F, Lemachatti A, Occelli C, Levraut J, Contenti J. Target-controlled infusion for emergency department procedural sedation: influence of age on required propofol concentration targets. Eur J Emerg Med. 2025 Jun 1;32(3):210-212. doi: 10.1097/MEJ.0000000000001220. Epub 2025 Apr 28. No abstract available.

  PMID: 40315032 RESULT

MeSH Terms

Conditions

Joint Dislocations; Emergencies

Interventions

Propofol

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fabien LEMOEL, PhD

  Emergency Department, Universitary Hospital of Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: May 9, 2019
• Primary Completion: October 25, 2020
• Study Completion: October 25, 2020
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)